아펜탈정의 생물학적 동등성 평가 = Bioequivalence Evaluation of Aceclofenac Tablets

다국어 초록 (Multilingual Abstract)

The bioequivalence of two aceclofenac tablets was evaluated in 14 normal volunteers (age 21∼29yrs) following oral administration. The test product was "Apental tablet" made by Asia Pharmaceutical Co. and the reference was "Airtal tablet" made by Daewoong Pharmaceutical Co.. After one tablet containing 100 mg aceclofenac was administered, blood was taken at predetermined time intervals and the concentration of the drug in plasma was quantitated with an HPLC method. AUC, C_max and T_max were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC, C_max and T_max between two products were 4.23%, 2.15% and 0%, respectively. The powers for AUC, C_max and T_max were ＞90%,＞90% and 85.8%, respectively. Confidence intervals were within ±20% for three parameters. All of these parameters met the criteria of KFDA for bioequivalence, indicating that "Apental tablet" is bioequivalent to "Airtal tablet". (Kor. J. Clin. Pharm. 1999; 9(1): 44-48)

목차 (Table of Contents)

• 실험재료 및 방법
• 시약 및 재료
• 용출시험
• 피험자 선정
• 투약 및 혈액 채취
• 혈장중 아세클로페낙의 정량
• 평가항목
• 실험결과 및 고찰
• 용출시험
• 혈장중 아세클로페낙의 정량
• 혈장중 아세클로페낙 농도 추이
• 평가항목에 대한 통계학적 고찰